BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2972300 · Received February 21, 2013

    Report

    Report Number
    3005099803-2013-00887
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WAS WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS PALLIATIVE TREATMENT FOR A STENOSIS CAUSED BY LARGE INTESTINE MALIGNANCY. THE COLONIC STRICTURE WAS APPROXIMATELY 3CM IN LENGTH. DURING THE PROCEDURE, THE STENT WAS IMPLANTED SUCCESSFULLY FROM THE SIGMOID TO THE RECTOSIGMOID COLON. ON (B)(6) 2013 AT MIDNIGHT, THE PATIENT COMPLAINED OF ABDOMINAL PAINS AND A FEVER. A CT SCAN WAS PERFORMED, WHICH REVEALED FREE AIR AND ASCITES FLUID. THE PHYSICIAN ASSESSED THAT A PERFORATION HAD OCCURRED AT THE SITE OF THE STENT. AN EMERGENCY SURGERY WAS PERFORMED ON (B)(6) 2013. DURING THE SURGERY, THE SECTION OF COLON INCLUDING THE STENOSIS, PERFORATION, AND STENT WAS REMOVED AND A STOMA WAS CREATED. FOLLOWING THE SURGERY, THE PATIENT CONDITION WAS STABLE AND THE PATIENT IS UNDER FOLLOW UP. IN THE PHYSICIAN'S ASSESSMENT, THE DILATION OF THE STENOSIS DUE TO THE EXPANSION OF THE STENT MAY HAVE CONTRIBUTED TO THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76265 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565110 15515232

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention